Lupin's Generic Breakthrough: USFDA Approval for Multiple Sclerosis Drug

Lupin has received USFDA approval for a generic drug to treat multiple sclerosis. Siponimod Tablets, bioequivalent to Mayzent, will be manufactured in Pithampur. The US market for Siponimod amounts to USD 195 million annually. Lupin's shares rose slightly post-announcement.


Devdiscourse News Desk | New Delhi | Updated: 05-12-2025 14:51 IST | Created: 05-12-2025 14:51 IST
Lupin's Generic Breakthrough: USFDA Approval for Multiple Sclerosis Drug
This image is AI-generated and does not depict any real-life event or location. It is a fictional representation created for illustrative purposes only.
  • Country:
  • India

Lupin, a notable drug manufacturer, has secured approval from the US Food and Drug Administration (USFDA) to market a generic medication for multiple sclerosis treatment.

The Mumbai-based company announced that it received tentative clearance for its Siponimod Tablets, designed in 0.25 mg, 1 mg, and 2 mg doses, mimicking Mayzent's formulation from Novartis Pharmaceuticals.

These tablets, aimed at managing various forms of multiple sclerosis, including relapsing and secondary progressive disease, will be produced at Lupin's facility in Pithampur. With estimated annual US sales reaching USD 195 million, the approval shines a light on Lupin's market prospects, as reflected in a minor increase in its stock value.

Give Feedback